The FDA is in flux, ESMO is approaching, and a series of clinical and regulatory catalysts could put biotech stocks in focus. John Gagliano and Sheff Sheffield mark their 20th episode together by reviewing developments and the companies on their radar. They discuss:

🔹 FDA leadership shakeup
🔹 ESMO in Madrid and the readouts
🔹 Catalysts to watch before year-end and early 2027.

In this episode, you’ll hear about:
Aldeyra Therapeutics (ALDX) and the potential relevance of the Outlook Therapeutics precedent.
Inovio (INO) and its accelerated approval review for recurrent respiratory papillomatosis.
NRx Pharma (NRXP) and its reported FDA progress with Ketafree
Unicycive Therapeutics (UNCY) and its manufacturing-focused turnaround story
Vivani Medical (VANI),
Fractyl Health (GUTS), and developments in obesity and metabolic programs
Savara (SVRA), and other companies facing important regulatory milestones
Gossamer Bio (GOSS) and more.

🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar
🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast
📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades

📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst
📲 Follow Sheff: https://x.com/SheffStation

Disclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode, John Gagliano and Sheff Sheffield discuss the biggest biotech catalysts heading into the final months of 2026. They examine continued big-pharma acquisition activity, Novo Nordisk’s pediatric obesity data, GLP-1 expansion, and the importance of pinpointing dates for clinical readouts, regulatory decisions, and conference presentations. You'll discover:

🔹 Why big pharma M&A could continue supporting small- and mid-cap biotech stocks
🔹 How GLP-1 developments and pediatric obesity data may expand the weight-loss market
🔹 How to evaluate catalyst timing, cash runway, institutional ownership, and clinical-trial data

Sheff is proud to support the Northwest Association for Blind Athletes. Join us in empowering life-changing opportunities for visually impaired youth and adults through sports and community engagement. You can support this as well at the link below:

Support NWABA: https://nwaba.org/support/other-ways-to-help/sheffstation/#join-sheff-station

🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar
🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast
📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades

📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst
📲 Follow Sheff: https://x.com/SheffStation

Disclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

In this episode features John Gagliano in conversation with Stephan Jackman, CEO and director of Alzamend, about the company’s mission, “Making Alzheimer’s just a memory,” and its pipeline in Alzheimer’s and related neuropsychiatric disorders. They cover how Alzamend is trying to improve on current treatments by focusing on safer, more targeted approaches, including a next-generation lithium and an autologous immunotherapeutic vaccine.

Alzamend Neuro Inc.
https://www.biopharmcatalyst.com/company/ALZN#/

📲 Follow Stephan Jackman and Alzamend Neuro:
- https://www.linkedin.com/in/stephan-jackman-4578328a
- https://www.linkedin.com/company/alzamend-neuro?trk=public_profile_topcard-current-company
- https://alzamend.com/

In this episode:

🔹 The real wedge in Alzheimer’s is not efficacy alone - it is safety plus usability
🔹 Personalization matters most when one-size-fits-all breaks down
🔹 A platform is more valuable than a single indication

🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar
🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast
📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades

📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst
📲 Follow Sheff: https://x.com/SheffStation

Disclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.